BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDICHOICE ULTRASOUND GEL

    MDR report key: 4226708 · Received October 30, 2014

    Report

    Report Number
    4226708
    Event Type
    Malfunction
    Date Received
    October 30, 2014
    Date of Event
    July 8, 2014
    Report Date
    October 29, 2014
    Manufacturer
    OWENS & MINOR DISTRIBUTION, INC.
    Product Code
    MUI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    PATIENT WENT FOR ULTRASOUND OF HIS HEART TODAY. COMPLAINED OF CHEST BOTHERING HIM DURING THE PROCEDURE. TOLD THE TECH AND THEN TOLD HIS WIFE UPON HIS RETURN BACK TO HIS ROOM. PER WIFE, IT LOOKS LIKE TWO BIG BLISTERS ON HIS CHEST AND THAT THE SKIN IS PUSHED TO THE SIDE; OPEN WOUND. STATES THAT WHEN HE TOLD THE TECH IT WAS SHARP, SHE SAID THAT OTHER PATIENTS HAVE COMPLAINED OF THE SAME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    694651 MEDICHOICE ULTRASOUND GEL MEDIA,COUPLING,ULTRASOUND MUI OWENS & MINOR DISTRIBUTION, INC. N/A 140302

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR